REVTORPYK Gedatolisib - (VIKTORIA-1)

July 14, 2026: Celcuity Inc. (NASDAQ: CELC) announced FDA approval of REVTORPYK (gedatolisib), a pan-class I PI3K (α/β/δ/γ) and mTORC1/2 inhibitor, in combination with fulvestrant, with or without palbociclib, for adults with HR-positive/HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected, after progression on or after at least one line of endocrine therapy in the metastatic setting.

Approval is based on the PIK3CA wild-type cohort of the Phase 3, open-label, global randomized VIKTORIA-1 trial in patients previously treated with CDK4/6 therapy and an aromatase inhibitor. REVTORPYK + palbociclib + fulvestrant improved median PFS to 9.3 months vs 2.0 months with fulvestrant (HR 0.24; p<0.0001) with ORR 32% (vs 1%) and median DOR 17.5 months. REVTORPYK + fulvestrant improved median PFS to 7.4 vs 2.0 months (HR 0.33; p<0.0001) with ORR 28% and median DOR 12.0 months.

Celcuity expects a late Q3 2026 commercial launch and will offer expanded access pre-launch. An sNDA for PIK3CA-mutated HR+/HER2- disease is planned for Q3 2026, supported by mutant-cohort VIKTORIA-1 data presented at ASCO 2026. Ongoing Phase 3 VIKTORIA-2 is evaluating first-line regimens in treatment-naive advanced HR+/HER2- cohorts. A webcast/conference call was scheduled for July 14, 2026 at 5:30 p.m. EDT.